- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07489456
Screening for Dysglycemia During Postpartum Period in Women With GDM
Strategies for Improving the Detection of Dysglycemia in the Postpartum Period in Women With Gestational Diabetes: Electronic Reminders and New Diagnostic Criteria
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Gestational diabetes is one of the most common complications during pregnancy. With the increase in obesity and overweight in the population, as well as the postponement of motherhood, its incidence has been steadily increasing.
It is associated with complications such as polyhydramnios, macrosomia, premature labor, fetal death, hypoglycemia, and neonatal respiratory distress. Given the increase in the incidence of gestational diabetes and its clinical and epidemiological importance, a better understanding of the disease can promote improved care and prevention of its complications.
Women diagnosed with gestational diabetes mellitus (GDM) are at increased risk of developing prediabetes and type 2 diabetes in the years following childbirth. For this reason, national and international guidelines recommend performing a 75g oral glucose tolerance test (OGTT-75g) in the postpartum period, usually between six and 12 weeks after delivery, as a strategy for reclassifying glycemic status and early identification of persistent metabolic changes.
Despite the clinical relevance of the OGTT-75g in the follow-up of women with GDM, the rate of attendance for the test is notoriously low, especially in public health services. The reasons are multifactorial and include task overload in the postpartum period, logistical barriers, low risk perception, and the absence of systematic strategies to reinforce attendance. Simple interventions, such as sending reminders via electronic messages, have shown promise.
Considering the clinical and epidemiological relevance of GDM and these two complementary challenges-low attendance rates for screening and the diagnostic limitations of the current protocol-we propose two lines of investigation in this study:
- to evaluate the impact of sending reminders via WhatsApp on the return rate for performing the 75g OGTT in the postpartum period; and
- to compare the prevalence of glycemic changes identified by two different diagnostic strategies: the traditional one (fasting and two-hour blood glucose) and the new one (fasting and one-hour blood glucose). The results obtained may contribute to the qualification of care protocols and the prevention of adverse metabolic outcomes in women with a history of GDM.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tatiana A Zaccara, MD PhD
- Phone Number: +551126616209
- Email: tatiana.assuncao@hc.fm.usp.br
Study Locations
-
-
São Paulo
-
São Paulo, São Paulo, Brazil, 05.403-905
- Recruiting
- University of Sao Paulo General Hospital
-
Contact:
- Tatiana A Zaccara, MD PhD
- Phone Number: +551126616209
- Email: tatiana.assuncao@hc.fm.usp.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of gestational diabetes mellitus, according to diagnostic criteria proposed by the IADPSG, namely:
- initial fasting blood glucose ≥ 92mg/dL OR
- 75g oral glucose tolerance test with fasting ≥ 92mg/dL or after 1h ≥ 180mg/dL or after 2h ≥ 153mg/dL Delivery performed at HC-FMUSP Scheduling of the 75g oral glucose tolerance test between 6 and 12 weeks after delivery Agreement with the informed consent form
Exclusion Criteria:
Withdrawal of consent Failure to complete the TOTG exam due to vomiting (exclusion from analysis 2 only)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Control Group (current practice): will not receive reminder messages for the exam.
|
|
|
Experimental: Intervention group
Intervention Group: will receive automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam.
If the patient does not attend, she will receive a single additional message on the following business day, offering the possibility of rescheduling.
Rescheduled exams will not receive new reminders.
The message sent will contain a read receipt request to ensure that the patient has received the text.
If the patient requests to reschedule the exam before the originally scheduled date, we will consider the new date as D for sending reminder messages.
|
Automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients that attend to the postpartum OGTT
Time Frame: From enrollment to the end of the recommended timeframe for postpartum OGTT (6 to 12 weeks after delivery)
|
Impact of electronic messages in the attendance rate of postpartum women with GDM at the TOTG-75g exam between 6 and 12 weeks after delivery
|
From enrollment to the end of the recommended timeframe for postpartum OGTT (6 to 12 weeks after delivery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dysglycemia rate according to diagnostic set of criteria
Time Frame: From enrollment to OGTT test (6 to 12 weeks after delivery)
|
Compare the prevalence of prediabetes and diabetes in the postpartum period according to two diagnostic strategies applied to the 75g OGTT: Strategy A (currently in use): fasting blood glucose measurements and measurements two hours after glucose loading Strategy B (under investigation): fasting blood glucose measurements and measurements one hour after glucose loading |
From enrollment to OGTT test (6 to 12 weeks after delivery)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Milluzzo A, Manuella L, Frittitta L, Sciacca L. Efficacy of a phone reminder to improve adherence to post-partum glucose tolerance testing after gestational diabetes and clinical predictors of post-partum follow-up compliance. Diabetes Research and Clinical Practice. 2024 Apr;210:111653. Available from: https://doi.org/10.1016/j.diabres.2024.111653
- Egan AM, Dunne FP. Rethinking Postpartum Glucose Assessment: Is One-Hour Testing the Key to Success? Vol. 48, Diabetes Care. American Diabetes Association Inc.; 2025. p. 874-6.
- Buysschaert M, Bergman M, Valensi P. 1-h post-load plasma glucose for detecting early stages of prediabetes. Vol. 48, Diabetes and Metabolism. Elsevier Masson s.r.l.; 2022.
- Retnakaran R, Ye C, Kramer CK, Hanley AJ, Connelly PW, Sermer M, et al. One-Hour Oral Glucose Tolerance Test for the Postpartum Reclassification of Women With Hyperglycemia in Pregnancy. Diabetes Care. 2025 Jun 1;48(6):887-95.
- McIntyre HD, Fuglsang J, Kampmann U, Knorr S, Ovesen P. Hyperglycemia in Pregnancy and Women's Health in the 21st Century. Vol. 19, International journal of environmental research and public health. NLM (Medline); 2022.
- Bozkurt L, Göbl CS, Pfligl L, Leitner K, Bancher-Todesca D, Luger A, et al. Pathophysiological characteristics and effects of obesity in women with early and late manifestation of gestational diabetes diagnosed by the International Association of Diabetes and Pregnancy Study Groups criteria. Journal of Clinical Endocrinology and Metabolism. 2015 Mar 1;100(3):1113-20.
- Hod M, Kapur A, Sacks DA, Hadar E, Agarwal M, Di Renzo GC, et al. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on gestational diabetes mellitus: A pragmatic guide for diagnosis, management, and care#. International Journal of Gynecology & Obstetrics [Internet]. 2015 Oct 1;131(S3):S173-211. Available from: https://doi.org/10.1016/S0020-7292(15)30033-3
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 95734326.5.0000.0068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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